About this role
Quality Engineer
Contract
Job Description
Our client, a Global Leader in the Medical Device Industry has an immediate opening for a Quality Engineer for a 12 month + Contract. Our client offers results-driven people a place where they can make a difference - every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.
The Quality Assurance Engineer will play a proactive role in supporting quality assurance, quality control and preventive activities to ensure compliance with regulations and standards. Collaborate with cross-functional teams, assist in resolving quality issues, and contribute to continuous improvement initiatives within manufacturing and quality processes.
Responsibilities
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Work closely with Operations and Business Functions to ensure quality performance of products and processes
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Collaborate cross-functionally with internal and external teams to resolve quality issues
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Own and manage internal and supplier-driven Non-Conformances (NCs), ensuring timely investigation and closure
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Support or own Corrective and Preventive Actions (CAPAs) through root cause analysis to closure
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Disposition of non-conforming product through MRB, issuing NCs as appropriate
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Communicate with suppliers regarding NCs and escalate Supplier Corrective Action Requests (SCARs) as needed
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Participate in the development and continuous improvement of internal manufacturing processes for existing products
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Review and support Change Management activities (both supplier and internal)
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Create and/or review new or revised procedures
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Maintain and analyze KPIs to monitor product and process quality; identify trends and implement corrective actions
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Support the execution and analysis of manufacturing complaints and product field actions
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Apply statistical methods for process analysis and control
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Provide QA support during internal and external audits
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Support process/equipment validation, qualification, and Measurement System Analysis (MSA)
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Execute internal quality deliverables for engineering changes, manufacturing transfers, and supplier changes
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Assist in manufacturing/product transfers between plants/facilities, performing appropriate quality activities
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Execute and analyze Quality Acceptance Tests (QATs)
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Support with product holds and executing containment Plans
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Support in risk management practices and tools, use knowledge in process risk. Support and provide input for risk management by identifying opportunities and weaknesses.
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Support and implement Lean principles through standardization and waste elimination
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Understanding of Human Error Prevention and the application of those principles to the manufacturing environment.
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Manage supplier relationships, including but not limited to, coordinating communications, monitoring performance, managing in house and external nonconformities and ensuring timely delivery of quality materials and services.
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Job Requirements
Qualifications
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Bachelors degree in technical/engineering required
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Familiar with ISO 13485, GDP, and GMP concepts
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Solid understanding of engineering and quality principles, including Risk Management, CAPA, Audits, and Statistics
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Proficient in Microsoft Word, Excel, and PowerPoint
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Strong problem-solving, analytical, and communication skills with high attention to detail
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Builds strong relationships through open communication, respect, and trust
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Embraces change with a continuous improvement mindset.
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Confident representing Quality in cross-functional settings
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Self-starter able to manage multiple tasks in a fast-paced environment
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Willing to work as part of a multi-site team; some travel required
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Knowledge of risk-based thinking and statistical concepts is a plus
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About Portage, MI
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Ready to take the next step in your career? Explore exciting job opportunities in and around Portage, Michigan with us today! Nestled in the southwest region of the Great Lakes State, Portage offers a perfect blend of picturesque landscapes, vibrant cultural scene, and abundant career growth opportunities. Imagine working in proximity to Kalamazoo Nature Center, cheering on the Kalamazoo Wings at Wings Event Center, and indulging in the famous Michigan cherry pies. With renowned art galleries like the Kalamazoo Institute of Arts, charming theaters like the Barn Theatre, and the nearby shores of Lake Michigan, Portage invites you to discover a world of possibilities. Let's find your dream job amidst the charm and beauty of Portage, MI!
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Contract positions
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Will be employed and paid hourly by iMPact Business Group. Benefits (medical, dental & vision) are available after 90 days of employment.
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Permanent placed employees
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Paid by and qualify for benefits in accordance with the policies of the hiring company.
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Submit your resume today to be considered for this position. A recruiter will review within a business day or two and will reach back out to you if they would like to discuss next steps.
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Internal Positions
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We have several internal positions at iMPact that we are hiring for. Please view our internal positions here.
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Recruiters
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Account Managers
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Learn more about working with iMPact Business Group
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iMPact Business Group is a professional staffing agency located in Grand Rapids, MI, and Tampa, FL. We were founded in 2004 and service candidates and clients nationwide. Our areas of specialization are in IT, Engineering, Finance/Accounting, and Business Administration/Process (HR, Marketing, Admin jobs, etc). Opportunities are available nationwide as well as remote.
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